Recall – Cytometry software may produce erroneous results

Company: Beckman Coulter, Inc.
Date of Enforcement Report: 8/18/2021
Class I

PRODUCT

Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 – Kaluza C Single Perpetual License C10575 – Kaluza C Single User 1-year License C10576 – Kaluza C 10 User Network License C10577 – Kaluza C 5 User Network License C10578 – Kaluza C Single Perpetual Educational License C10579 – Kaluza C Single User 1-year Educational License C10580 – Kaluza C 10 User Network Educational License C10581 – Kaluza C 5 User Network Educational License and C21166 – Kaluza C Program DVD v1.0

Recall Number: Z-2241-2021

REASON

Software anomalies that may lead to the generation of erroneous results.

RECALLING FIRM/MANUFACTURER

Beckman Coulter, Inc. on 6/23/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

1,085 (482 US & 603 OUS)

DISTRIBUTION

U.S. Nationwide and International

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.